MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma
Recruitment status was Active, not recruiting
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | June 12, 2012 | ||||
Start Date ICMJE | March 2009 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Anti-tumor response as measured by RECIST criteria [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00866177 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Response rates within various factors such as PTEN status [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma | ||||
Official Title ICMJE | Phase II Trial of Hyd-sulfate AZD6244 [NSC 748727] in Patients With BRAF or NRAS Mutated Melanomas | ||||
Brief Summary | RATIONALE: MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients with stage III or stage IV melanoma. |
||||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are stratified according to pAKT expression (low vs high). Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Tumor tissue samples are collected for correlative laboratory studies. Samples are assessed for expression of pAKT, pPRAS40, and PTEN by IHC and mutations in BRAF, NRAS, KIT, and PIK3CAP by MALDI-TOF. PTEN is sequenced in tumors using whole genome amplification followed by high-throughput bidirectional dideoxynucleotide sequencing of PCR-amplified gene products After completion of study treatment, patients are followed for 4 weeks. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Melanoma (Skin) | ||||
Intervention ICMJE |
|
||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866177 | ||||
Other Study ID Numbers ICMJE | CDR0000637669, MSKCC-09003 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | David Paul Kelsen, Memorial Sloan-Kettering Cancer Center | ||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
|
||||
Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |